Lab Matters Fall 2020 - Page 53

Establishing a CDC Standardized Approach to Test Deployment
A . Muehlenbachs , J . Chaitram , Workgroup members : T . Aden , K . Anderson , R . Jones , C . Luquez , Z . Weiner , S . Bearden , J . Bowzard , B . Boylan , S . Chochua , S . Courtney , E . Dietrich , H . Hughes , S . Lindstrom , J . Kools , A . McCollum , J . Meadows , T . Parker , C . D . Pham , L . Rose , E . Secor , S . Spies , A . Trujillo ; Centers for Disease Control and Prevention , Atlanta , GA
Public health laboratories conduct diagnostic and surveillance testing using CDC-developed tests under applicable regulations , standards , and quality system requirements . Recent recommendations from the Government Accountability Office ( GAO ) and the Association of Public Health Laboratories ( APHL ) have highlighted the need for a standardized process to improve CDC ’ s test deployment practices . To meet these recommendations , CDC convened a chartered working group comprised of internal program subject matter experts with broad experience in laboratory preparedness , test deployment , procedure implementation for diagnostic use or surveillance , collaboration with external partners , and regulatory affairs .
This working group has reviewed elements important to the overall standardization process . Such elements include consideration of the laboratory equipment used by partner laboratories , the availability of reference materials for test validation , the importance of providing procedural details to meet regulatory requirements , and the need for guidance on result interpretation to implement a sustainable and robust deployment process to meet public health laboratory needs .
Here , we provide 1 ) a brief overview of the objectives , activities , and priorities of the CDC working group to support the standardization of laboratory practices , strategic coordination , and improved communication between CDC and public health partners to streamline test deployment practices , and 2 ) a venue to obtain feedback on these efforts from state , local and territorial public health laboratory representatives .
Presenter : Atis Muehlenbachs , Centers for Disease Control and Prevention , Atlanta , GA , vkd6 @ cdc . gov
Next Generation Sequencing Quality Initiative
R . Hutchins 1 , C . Hanigan 2 , D . Arambula 1 , J . Bratton 1 , A . Muehlenbachs 1 , C . Fitzgerald 1 ; 1 Centers for Disease Control and Prevention , Atlanta , GA , 2 Association of Public Health Laboratories , Silver Spring , MD
Next Generation Sequencing ( NGS ) is being broadly implemented across clinical and state and local public health laboratories , with diverse applications including infectious disease diagnostic testing as well as public health surveillance and outbreak response . Although NGS assays are becoming more routinely available , the laboratory and data analysis workflows being developed across total test processes can be fragmented and complex . This leads to numerous challenges in the implementation of NGS assays in the clinical and public health laboratory settings for test validation , quality control , quality assurance , result interpretation , reporting , and compliance with regulatory requirements such as CLIA . The Centers for Disease Control and Prevention ( CDC ), the Association of Public Health Laboratories ( APHL ), and state public health laboratories ( PHLs ) are partnering to develop an NGS-focused quality management system ( QMS ) to address challenges CDC and state PHLs encounter when they develop and implement NGSbased tests . The initiative will create free , customizable , ready-toimplement guidance documents , standard operating procedures , and forms . This project leverages the ongoing expertise and activities of the CDC NGS Quality workgroup and review board , APHL NGS subcommittee , APHL Laboratory Systems and Standards Committee , and the ad hoc PulseNet Steering Committee . The TCC reaches across CDC laboratories and state PHLs to collect , develop , and distribute QMS tools and guidance to help build this foundational QMS for NGS testing . The TCC conducts interactive discussions to develop standardized quality practices and protocols to ensure NGS test results are consistent , accurate , and adhere to regulatory requirements , where applicable . The TCC develops SOPs , forms , and tools to aid labs implementing quality processes for NGS methods . These documents and tools are housed on a public webpage and are available for use by all laboratories . Topics addressed within these resources include Personnel Management , Equipment Management , NGS Process Management , Internal Laboratory Assessments , Facilities and Safety , and NGS Information Management .
Presenter : Rebecca Hutchins , Centers for Disease Control and Prevention , Atlanta , GA , ibo7 @ cdc . gov
A Continuous Quality Improvement of the Texas AR Lab Network Testing Process
J . Miranda , V . Telles and R . Lee , Texas Department of State Health Services Laboratory , Austin , TX
Background : AR Lab Network laboratories provide critical services to rapidly detect antibiotic resistance and produce data to inform responses , prevent or contain spread of infections , and protect people . Over the past years , the Texas DSHS AR laboratory had undergone changes in testing type , technology , and workload that prompted an evaluation of the current testing process to improve efficiency and keep meeting public health needs and regulatory requirements . The purpose of this continuous quality improvement project is to review the Texas AR Lab Network testing process to assess , identify , and implement improvement opportunities .
Methods : This quality improvement project was based on the five stages of Lean Six Sigma methodologies : Define , Measure , Analyze , Improve , and Control ( DMAIC ). To define the current state , six months of data were analyzed , processes were observed and interviews with laboratory staff were used to define problems that resulted in inefficiency and specify goals of the project . Baseline process performance was measured by mapping and timing steps of testing processes and calculating testing completion times . Review , visualization , and analysis of data collected enabled the identification of potential causes of the problem and improvement opportunities . Potential ideas and solutions were proposed through brainstorming with laboratory staff and management . The best and most practical solution was then selected , approved , and implemented . After changes were applied , data were recollected and analyzed to measure and confirm improvements .
Results and Conclusion : The overall goal of this study was to simplify the AR laboratory work process by eliminating non-valueadded steps . The pre-analytical and analytical phases of the AR testing process were both reviewed and no necessary changes were identified . The main bottleneck was identified in the post
Quality Systems
Fall 2020 LAB MATTERS 51